Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072096
Company: PERRIGO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/08/1987 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/13/2016 SUPPL-99 Labeling

Label is not available on this site.

06/23/2016 SUPPL-97 Labeling-Container/Carton Labels

Label is not available on this site.

11/26/2012 SUPPL-76 Labeling-Container/Carton Labels

Label is not available on this site.

01/25/2010 SUPPL-72 Labeling

Label is not available on this site.

01/16/2008 SUPPL-70 Labeling

Label is not available on this site.

03/22/2006 SUPPL-63 Labeling

Label is not available on this site.

03/28/2003 SUPPL-44 Labeling

Label is not available on this site.

11/26/2002 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

11/26/2002 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

11/26/2002 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

09/12/2001 SUPPL-37 Labeling

Label is not available on this site.

08/21/2001 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/2001 SUPPL-35 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/26/2000 SUPPL-34 Labeling

Label is not available on this site.

02/20/2004 SUPPL-33 Labeling

Label is not available on this site.

06/19/2001 SUPPL-32 Manufacturing (CMC)-Facility

Label is not available on this site.

03/27/2000 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

10/01/1999 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

03/11/1999 SUPPL-29 Labeling

Label is not available on this site.

06/23/1999 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

06/23/1999 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

07/15/1996 SUPPL-23 Labeling

Label is not available on this site.

07/25/1997 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

07/25/1997 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

03/22/1996 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

07/22/1996 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

06/01/1995 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

07/15/1996 SUPPL-16 Labeling

Label is not available on this site.

04/06/1995 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

02/13/1995 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

07/11/1994 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/06/1994 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

01/11/1994 SUPPL-11 Labeling

Label is not available on this site.

01/11/1994 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

11/15/1993 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/03/1991 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

11/30/1992 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/30/1992 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/11/1993 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/28/1989 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

IBUPROFEN

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET;ORAL; 200MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ADVIL IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 018989 PFIZER
IBU-TAB 200 IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 071057 ALRA
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 079233 AMNEAL PHARMS
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 071333 AMNEAL PHARMS NY
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 072199 AMNEAL PHARMS NY
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 208865 AUROBINDO PHARMA LTD
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 076460 AVEMA PHARMA
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 072299 CONTRACT PHARMACAL
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 075661 DR REDDYS LA
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 076117 DR REDDYS LABS INC
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 079174 GRANULES INDIA
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 202312 GRANULES INDIA LTD
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 075010 LNK
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 075139 LNK
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 091237 MARKSANS PHARMA
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 091239 MARKSANS PHARMA
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 073019 MCNEIL
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 070985 MERRO PHARM
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 071163 OHM
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 070481 PAR PHARM
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 072096 PERRIGO
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 075995 PERRIGO
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 077349 PERRIGO R AND D
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 206990 SHANDONG XINHUA
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 207095 SHANDONG XINHUA
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 079129 STRIDES PHARMA
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 091355 STRIDES PHARMA
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 206989 STRIDES PHARMA
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 207052 STRIDES PHARMA
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 071229 VINTAGE PHARMS
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 071639 VINTAGE PHARMS
MOTRIN IB IBUPROFEN 200MG TABLET;ORAL Over-the-counter Yes 019012 J AND J CONSUMER INC
TAB-PROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 072095 PERRIGO

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